This Funding Opportunity Announcement (FOA) is dedicated to the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, and cell therapies) for disorders that fall under the NINDS mission. An identified candidate, which has sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to the CREATE Bio Development Track. The FOA supports Investigational New Drug (IND)-enabling studies for the candidate and early-phase clinical trials. At the end of the funding period, a successful project should have an IND application submitted to the U.S. Food and Drug Administration (FDA), at a minimum. The program supports early-phase clinical trials, although these are not required.